On August 14, 2000, the U.S. Food and Drug Administration released its final guidance on the practice of reusing medical devices that are intended to be used only once. In the guidance, titled “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals” (http://www.fda.gov/cdrh/comp/guidance/1168.pdf), FDA states that it will regulate hospitals and third-party reprocessors engaged in reprocessing of single-use devices (SUDs) the same way the agency now regulates original equipment manufacturers.
The reprocessing of medical devices labeled for single-use has grown steadily in recent years, as has the complexity of the devices being reprocessed. This trend has intensified concern about patient safety, informed consent, the ethics of this practice, and the equitable regulation of the original manufacturer and reprocessors. The goal of the new SUDs reuse policy is to protect public health by assuring that the practice of reprocessing and reusing SUDs is based on good science while ensuring that the regulatory requirements are equitable to all parties. FDA will rely heavily on hospitals meeting the requirements of the Quality System regulation since it is most applicable to reprocessing and applies to all device classes.